高效液相色谱法测定盐酸氨溴索葡萄糖注射液中5-HMF含量

Determination of 5-HMF in ambroxol hydrochloride and glucose injection by high performance liquicl chromatography

【目的】建立高效液相色谱法测定盐酸氨溴索葡萄糖注射液中5-羟甲基糠醛的含量。【方法】采用CAPCELL PAK C18色谱柱（250 mm×4.6 mm,5μm）,流动相：甲醇-0.05%磷酸溶液（10：100）,流速1.0 ml/min,检测波长284 nm。【结果】5-HMF在0.295~3.54μg/ml浓度范围内线性较好（r=0.9998）,平均加样回收率为99.65%（n=6）,RSD为0.46%。【结论】本方法准确,重复性好,可用于盐酸氨溴索葡萄糖注射液中的5-HMF的含量控制。

[Objective] To establish a method for determination of 5-HMF in Ambroxol Hydrochloride and Glucose Injection by HPLC. [Methods] CAPCELL PAK C18 column （250 mm × 4.6 mm, 5 um） was used, The mobile phase was methanol- 0.05% phosphoric acid （10： 100）, The flow rate was 1.0ml/min, The detection wavelength was 284 nm. [ Results] The linear relationship of HMF was well（r = 0.9998）.The mean recoveries was 99.65%（n = 6）. [Conclusion]The method is accurate, good in recoveries. It can be used for determination of 5-HMF in Ambroxol Hvdrochloride and Glucose Injection.